NC TREK™ 1012446-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648151705), received between Feb 14, 2018 and Oct 28, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 2.25X15MM NC TREK BALLOON DILATATION CATHETER WAS ATTEMPTED TO ADVANCE; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL OF THE DEVICE RESISTANCE WAS MET WITH ANATOMY. NO DEVICE WAS ABLE CROSS AND A ROTABLATOR HAS BEEN PLANNED FOR A LATE DATE. THERE WERE NO ADVERSE PATIENTS EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691642 ↗
• MalfunctionJan 17, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY BUT REACHED THE TARGET LESION. THE BDC WAS INFLATED ONE TIME TO 18 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND ANOTHER SAME SIZE NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13270498 ↗
• MalfunctionDec 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, HEAVILY CALCIFIED, AND CHRONIC TOTALLY OCCLUDED LESION IN THE FIRST AND SECOND DIAGONAL ARTERY AND A 90% STENOSED, HEAVILY TORTUOUS, HEAVILY CALCIFIED, AND CHRONIC TOTALLY OCCLUDED LESION IN THE OBTUSE MARGINAL ARTERY. FOLLOWING THROMBUS ASPIRATION, PRE-DILATATION WAS PERFORMED WITH A 2.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) AND A 2.5X48MM XIENCE STENT WAS DEPLOYED WITHOUT ISSUES. A 2.5X15MM NC TREK BDC WAS ADVANCED TO THE SECOND DIAGONAL ARTERY AND A 2.5X20MM NC TREK BDC WAS ADVANCED TO THE ANTERIOR DESCENDING ARTERY TO PERFORM KISSING BALLOON ANGIOPLASTY; HOWEVER, THE 2.5X15MM BDC WAS INFLATED TO 12 ATMOSPHERES (ATMS) AND THE BALLOON RUPTURED. THE BDC WAS REMOVED AND NEW UNSPECIFIED DEVICE WAS USED SUCCESSFULLY. A 2.25X15MM BALLOON WAS ADVANCED TO THE FIRST DIAGONAL ARTERY, BUT THE BALLOON RUPTURED WHEN INFLATED TO 12 ATMS. THE BDC WAS REMOVED AND NEW UNSPECIFIED DEVICE WAS USED SUCCESSFULLY. A 2.5X20MM NC TREK BDC WAS ADVANCED TO THE OBTUSE MARGINAL ARTERY AND INFLATED TO 12 ATMS, BUT AGAIN THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A 3.0X20 NON-ABBOTT BALLOON WAS USED SUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11095579 ↗
• MalfunctionOct 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED DE NOVO RIGHT CORONARY ARTERY THAT IS 90% STENOSED. A 2.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES AT THE FIRST INFLATION. ANOTHER NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENTS EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10693636 ↗
• MalfunctionOct 1, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. THE 2.25X15MM NC TREK BALLOON DILATATION CATHETER MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON RUPTURED AT 14ATM ON THE FIRST INFLATION. THE DEVICE WAS REPLACED WITH A NEW NON-ABBOTT NC BALLOON TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617153 ↗
• MalfunctionNov 1, 2019Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY THAT WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE 2.25 X 15 NC TREK BALLOON WAS AIR ASPIRATED INSIDE THE ANATOMY AND RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269719 ↗
• MalfunctionNov 6, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH NO TORTUOSITY AND MODERATE CALCIFICATION. FOLLOWING PRE-DILATION WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC), A 2.25 X 15 MM NC TREK RX BDC WAS ADVANCED TO THE LESION, WITH RESISTANCE FROM THE ANATOMY, FOR ADDITIONAL DILATATION. THE NC TREK RX BALLOON RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS. THE BDC WAS SIMPLY REPLACED WITH AN ADDITIONAL UNSPECIFIED BDC TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042665 ↗
• MalfunctionFeb 14, 2018Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, ECCENTRIC, AND HEAVILY CALCIFIED DISTAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. DURING PRE-DILATATION, A NON-ABBOTT BALLOON CATHETER AND AN UNSPECIFIED GUIDE WIRE CROSSED THE TARGET LESION, BUT THE LESION DID NOT FULLY EXPAND. A 2.25 X 15 MM NC TREK BALLOON WAS USED FOR ADDITIONAL DILATATION. THERE WAS RESISTANCE ADVANCING THE BALLOON WITH THE ANATOMY. THEN THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES. THE NC TREK BALLOON WAS REMOVED AND A NON-ABBOTT BALLOON CATHETER WITH A HIGHER PRESSURE WAS USED TO CONTINUE WITH DILATATION. THE PROCEDURE SUCCESSFULLY COMPLETED AFTER STENTING. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270008 ↗